Medical Device Design Services

Our team of specialized medical device designers, developers, and project managers use the latest technologies and FDA guidelines to meet your project’s specific needs, tackle challenges efficiently, and accelerate market entry.

Hear From Our Happy Clients

Our clients’ experiences speak volumes about our commitment to innovation and quality. Here, you can read firsthand accounts of how Vantage MedTech has positively impacted various medical technology projects.

Hear From Our Happy Clients

Our clients’ experiences speak volumes about our commitment to innovation and quality. Here, you can read firsthand accounts of how Vantage MedTech has positively impacted various medical technology projects.
My relationship with Vantage MedTech spans three different companies and 15 years. I return to the Vantage MedTech team because they consistently deliver innovative solutions in a timely and cost-effective manner. I plan to continue this relationship for many years to come!
Vantage MedTech has provided us with a broad range of expertise, from electrical and software design to quality assurance and regulatory affairs. It would have been unlikely we could have hit our scheduled milestones without their help.
We were a young start up with a great technology, but were running into issues that our manufacturing partner could not explain. Over a year later and still no clear solution, I engaged Vantage MedTech to perform an independent analysis. Within 24 hours, they not only identified the issue, but also presented solutions to correct it. Vantage MedTech came forward with the level of expertise that was necessary to help turn around the situation, allowing REACT to bring our advanced neuromuscular therapy to patients who need it.
I have had the pleasure of working with Vantage MedTech team for the past seven years. The Vantage team is extremely professional, responsive, and collaborative. I know that I can always count on the Vantage MedTech Team to provide a quality product that will meet the product requirements.

Director of R&D

Several Medical Device & Life Sciences Firms


Katalyst Surgical

Kenneth C. Paulus

Founder & CEO, REACT Holdings & Pelvic Wave

Peter J. Oehlberg

Director, Technical Operations Bracco Diagnostics Inc


Medical Device Design Service Offerings

Full-Service Product Development

Streamline your device's journey to market by ensuring all user needs and regulatory requirements are met.

Advantage Platforms®

Our leasable pre-existing base platform systems are customizable to match your vision.

UX Design

Improve user experience with our focus on usability and human factors engineering.

Risk Management

Proactively identify potential device risks while maintaining project timelines and budgets.

Simplify Compliance

Adhere to the highest industry standards with our assistance in developing quality systems.

Electromechanical Hardware Development

Develop innovative hardware designs with our advanced circuit and system design expertise.


Secure your medical device software by keeping your design up-to-date with FDA cybersecurity standards.


Prototype effectively using our in-house ISO 14971 standardized rapid 3D prototyping services.

Account and Program Management

Personalized client experience ensuring a seamless strategic project approach backed by weekly meetings and clear project reporting.

Our Proven 4-Step Process

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This initial program phase is used to identify key requirements necessary to bring your product to market, built upon user needs and intended use. Assessing concepts and demonstrating feasibility of those concepts define how we proceed towards a design that meets your needs.

Rely on partners who can adapt to your needs, wherever you are in your journey

Our depth of expertise in specific clinical segments is strengthened by our dedicated team, refined processes, and specialized portfolio and proprietary platforms.

Years of experience
On time delivery
Successful projects
Specialized medical device engineers
Experienced Partner

Reduce execution risk by working with a medical device design company known for over 1600+ medical devices developed.

Advantage Platforms®

Leverage our proprietary platform architecture and reduce development timelines by up to 60%.

Expert Team Collaboration

Our in-house team of specialized engineers will bring your medical device from concept to reality with precision and care.

Medical Device Design Services
Device Design Services

Reduce execution risk by partnering with an experienced medical device design company

Start your next medical device project by partnering with a company that has successfully gained approval for over 1,600 medical devices.

Our team of experienced program managers and engineers will develop a project plan for your device following our robust 4 stage development process, providing clear planning, tracking, and execution.

During this process, we will leverage a customized team of in-house quality, regulatory, mechanical, industrial, software, electrical, test and manufacturing engineers to bring your specifications to reality.

Get support you need for all stages of the medical device lifecycle

Whether you’re seeking early stage feasibility confidence, medical device design guidance, manufacturing reliance, or a combination of services, let’s meet and discuss how we can partner to support your medical device program needs.


Vantage MedTech is proud to be recognized for our certified excellence in medtech innovation and manufacturing.


* Held by RBC Medical Innovations
** Held by Sterling Medical Devices

Frequently Asked Questions

What Are The Standards For Medical Device Design?

The standards for medical device design include adherence to ISO 13485 for quality management systems, compliance with ISO 14971 for risk management, and meeting specific regulations like the FDA’s Quality System Regulation for medical devices.

These standards guide the design process, from initial concept to final product, focusing on user needs, product performance, and patient safety. Regular audits and reviews to ensure these standards are met throughout the device's lifecycle.

What Factors Need to Be Considered in The Medical Device Design Process?

During the medical device design process, it's important to consider the following factors:

  • User and Patient Safety: the device is safe for both users and patients.
  • Medical Necessity: the device must meet specific healthcare needs.
  • Regulatory Compliance: adherence to relevant regulations.
  • Usability: design for ease of use by healthcare professionals and patients.
  • Durability and Reliability: the device should be dependable and long-lasting.
  • Cost-Effectiveness: balance quality and affordability.

What Are ISO 13485 Requirements?

ISO 13485 sets requirements for a comprehensive quality management system in the design and manufacture of medical devices.

Requirements include:

  • Establishing well-defined processes
  • Effective risk management
  • Maintaining proper documentation
  • Implementing strict quality control measures
  • Regular internal audits
  • Corrective and preventive actions
  • Continuous improvement processes

This standard ensures that medical devices are consistently designed, produced, and distributed to meet both regulatory and customer requirements.

What Is The Difference Between ISO 13485 & GMP?

ISO 13485 and GMP (Good Manufacturing Practice) differ in scope and application.

ISO 13485 is an international standard that outlines requirements for a quality management system in the medical device industry. It ensures consistent quality, product safety, and compliance with customer and regulatory requirements.

GMP is enforced by the FDA in the USA. It focuses on the actual production process, including raw materials, staff training, and facility hygiene.

Do Class II Medical Devices Require Design Controls?

Class II medical devices do require design controls. The FDA mandates these controls to ensure that devices meet user needs, intended uses, and specified requirements.

Design controls are a systematic set of practices that manufacturers must follow during the development process. They include defining user needs, establishing design inputs and outputs, verifying that designs meet requirements, validating device effectiveness for intended use, and maintaining comprehensive design documentation.